FDA.reportPublic FDA data

Cold-EEZE

Manufacturer
ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.
Effective date
2016-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:54

Label at a glance#

ProductCold-EEZE Childrens Nighttime Cold and Cough Relief
Active ingredientAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Label structure10 sections

Indications and uses

temporary relief for these common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion runny nose sneezing cough controls cough to help your child get to sleep temporarily reduces fever

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning ) if needed, repeat dose every 4 hours while symptoms last do not give more than 5 days unless directed by a doctor measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter children 6 to under 12 years of a...

Storage and handling

each 10 mL contains: sodium 6 mg store between 20-25°C (68-77°F) dosing cup provided do not refrigerate dosing cup provided tamper evident: do not use if foil seal under bottle cap is open or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each 10 mL)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 12.5mgAntihistamine/cough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporary relief for these common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • runny nose
    • sneezing
    • cough
  • controls cough to help your child get to sleep
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions.
Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Avoid foods or beverages that contain caffeine.

SPL UNCLASSIFIED SECTION

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • with any other drug containing diphenhydramine, even one used on the skin
  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • fever gets worse, or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 days unless directed by a doctor
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours; do not give more than 5 doses in any 24-hour period
  • children under 6 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 6 mg
  • store between 20-25°C (68-77°F)
  • dosing cup provided
  • do not refrigerate
  • dosing cup provided
  • tamper evident: do not use if foil seal under bottle cap is open or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-800-505-2653
(M-F: 9AM-5PM EST)
You may also report side effects to this phone number

SPL UNCLASSIFIED SECTION

Manufactured for and
Distributed by:
ProPhase Labs, Inc.
PO Box 1349
Doylestown, PA 18901

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's
Cold-EEZE®
Nighttime
Cold & Cough

3001000213--47011

NDC 61941-0401-1

Acetaminophen 325 mg • Pain Reliever/Fever Reducer

Diphenhydramine HCl 12.5 mg • Antihistamine/Cough Suppressant

Phenylephrine HCl 5 mg • Nasal Decongestant

MULTI-SYMPTOM

Relief of:

  • Cough
  • Sore Throat
  • Fever
  • Stuffy Nose

Alcohol Free

Berry Flavor

For Ages 6+
6 fl oz (180 mL)

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN1
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY1
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY1
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY1
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY1
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-0401-12020-01-31C16284748780-19d75b9d0-322f-f424-e053-dadaa90a57ceCold-EEZE ® Children's Nighttime Cold & Cough Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0401-1Cold-EEZE Childrens Nighttime Cold and Cough Relief180 mL in 1 BOTTLE, UNIT-DOSELIQUID1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0401COLD-EEZE CHILDRENS NIGHTTIME COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PROPHASE LABS, INC.]1Legacy NDC, 1 package rows20160205_74cef3aa-282f-4244-9541-c35e2109c85a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61941-040161941-0401-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
Diphenhydramine HydrochlorideTC2D6JAD40ACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
Anhydrous Citric AcidXF417D3PSLIACT
Edetate Disodium7FLD91C86KIACT
FD&C Blue NO. 1H3R47K3TBDIACT
FD&C Red NO. 40WZB9127XOAIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Propyl Gallate8D4SNN7V92IACT
Water059QF0KO0RIACT
Sodium BenzoateOJ245FE5EUIACT
Sodium Citrate, Unspecified Form1Q73Q2JULRIACT
Sorbitol506T60A25RIACT
Sucralose96K6UQ3ZD4IACT
Xanthan GumTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a56a8bf2-0414-4a19-8321-eba58c3d5ed574cef3aa-282f-4244-9541-c35e2109c85a2016-01-29WarningsExact identifier
spl id: a56a8bf2-0414-4a19-8321-eba58c3d5ed5
spl set id: 74cef3aa-282f-4244-9541-c35e2109c85a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.